SAREUM HOLDINGS PLC

("Sareum" or the “Company")

AGM Statement

Cambridge, UK, 15 December 2020 – Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases, will hold its Annual General Meeting today, at 10:00 a.m. via the virtual Investor Meet Company platform.

As previously announced, shareholders wishing to join the AGM remotely and participate in the Q&A session should register with IMC at: www.investormeetcompany.com/sareum-holdings-plc/register-investor.

At the AGM, the Company’s Non-Executive Chairman, Dr Stephen Parker, will make the following statement:

“The past year has been a challenging period for many people and companies. We are, however, pleased to report that Sareum has adapted well to the new working conditions and constraints imposed by the Covid-19 pandemic. The Company has made good further progress and has seized an opportunity to obtain government funding to investigate one of its drug candidates as a potential treatment for Covid-19.

Our key focus remains on advancing the development of our two TYK2/JAK1 programmes, namely SDC-1801, targeting autoimmune diseases, and SDC-1802, targeting cancer.

For SDC-1801, which is our near-term focus, we conducted and completed initial toxicology studies in rodents demonstrating excellent tolerability and established its manufacturing process. In recent months, we developed a new formulation, specifically designed to deliver higher exposure levels of the molecule, which we are now testing in additional toxicology studies, with a targeted completion date early in the new year.

Data from these studies will form part of the planned Clinical Trial Application (“CTA”), which we aim to submit in the first quarter of 2021, and if approved would allow the start of clinical studies with SDC-1801. This would clearly be an important milestone for the Company.

In addition, in December 2020, we were granted £174,000 by UK Research & Innovation to investigate the therapeutic potential of SDC-1801 in severe phase Covid-19. The project began immediately and is expected to take approximately six months to complete.

Our aim is to investigate whether treatment of cells infected with SARS-CoV-2 with SDC-1801 can block the over-active inflammatory response (known as a “cytokine storm”), which can become life threatening for patients.

The scientific rationale for this project received a significant boost by data published last week in Nature of DNA studies from severe Covid-19 patients that indicated TYK2 to be a key gene involved in causing the “cytokine storm” that leads to progression of severe disease in patients.

Our project will also investigate if treatment with SDC-1801 in disease models can re-establish protection against bacterial pneumonia following SARS-CoV-2 infection.

Positive results from these studies may also highlight the broader potential for SDC-1801 as a treatment for severe and life-threatening inflammation that can occur with other viral infections.

We look forward to reporting the outcome of these initial studies in the second half of 2021.

With regards to our second TYK2/JAK1 inhibitor candidate, SDC-1802, formulation work for oral dosing was completed during the year and toxicology studies and further manufacturing work continue. During the year, Sareum presented new findings showing that SDC-1802, dosed orally as a monotherapy and in combination with chemotherapy, significantly reduced tumour growth in models of solid tumours and blood cancers.

This adds to the growing evidence for the potential of SDC-1802 in cancer and we continue to progress its development behind SDC-1801.

Turning to our licensed programmes; in March 2020 we announced a global licensing deal for our FLT3+Aurora kinase inhibitor targeting blood cancers with a China-based specialty pharmaceutical company. Sareum received an upfront payment and is eligible to receive an additional c.£0.90 million dependent on certain milestones being achieved by January 2021 and the Company will provide an update in this regard in due course.  Sareum is also eligible to receive a further development-based milestone, and revenues upon the commercialisation of any products resulting from the agreement.

Development of our licensed Chk1 inhibitor, SRA737, over the past 18 months has been frustrating for the Board. This is because, following the presentation of promising data from its Phase 1/2 trials in June 2019, the licence holder, Sierra Oncology Inc. (“Sierra”), put further SRA737 development on hold while it explored options to fund this development.

In November 2020, Sierra and CRT Pioneer Fund LP (“CPF”) agreed an amendment to the licence agreement that reduces the aggregate outstanding milestones from up to $319.5 million to up to $290.0 million, including a milestone payment of $2.0 million upon the dosing of the first patient in the next clinical trial of SRA737.

Sareum continues to be eligible for 27.5% of the economics of the CRT Licence Agreement, as amended, and while the aggregate level of milestone payments is reduced, we are confident that this amendment will expedite the SRA737 programme advancing in a more timely manner.

We continue to believe that, based on preclinical and early clinical data, SRA737 holds great promise for the treatment of cancer, particularly in combination with existing treatments. We will provide further updates on progress as and when Sierra makes further disclosures in relation to the development of SRA737.

Turning to business development, this is critical to the Company’s strategy of partnering its assets at late preclinical or early clinical stage balancing the cost versus risk/returns implications of its individual programmes. The Company continues to actively engage with potential partners with a view to securing commercial licences for its TYK2/JAK1 programme. We will, as usual, keep shareholders updated in this regard as appropriate.

In its fiscal year ended 30 June 2020, Sareum reported a loss after tax of £0.99 million versus a loss of £1.45 million in 2019. Cash at the period end was £1.80 million versus £1.0 million as of 31 December 2019 and £0.92 million as of 30 June 2019, reflecting the Company’s careful management of its cash resources, including the voluntary salary deferral scheme entered by all directors in December 2019 and updated in July 2020.

In June 2020, the Company successfully raised £1.02 million in gross proceeds through a placing by Hybridan LLP in conjunction with an offer via PrimaryBid and received an R&D Tax Credit of £0.23 million in January 2020. These proceeds are enabling Sareum to progress further its TYK2/JAK1 drug development programmes as well as providing support for working capital purposes.

The Board continues to actively monitor the working capital position of the company and has taken steps to maximise the cash runway, to ensure that the two TYK2/JAK1 compounds are prioritised and adequately resourced.

In summary, the Board believes that against the backdrop of the Covid-19 pandemic, Sareum has made further good progress with its proprietary TYK2/JAK1 programmes.

We now have the exciting prospect of submitting our first CTA for approval in the first quarter of 2021, a key step in allowing the first in human studies with SDC-1801 to begin.

In addition, we have executed an out-licensing deal for our FLT3+Aurora kinase inhibitor. We also recognise that the recently amended deal between Sierra and CPF on SRA737 is a key step in restarting the clinical advancement of this promising asset.

In this year more than any other, I would like to thank our shareholders, suppliers, contractors and other stakeholders for their continued support and look forward to providing further updates on progress as we move forward in 2021.”

 

For further information, please contact:

Sareum Holdings plc

Tim Mitchell, CEO

 

 

01223 497 700

Strand Hanson Limited (Nominated Adviser)

James Dance / Richard Tulloch

 

 

020 7409 3494

Hybridan LLP (Nominated Broker)

Claire Noyce / John Beresford-Peirse

 

 

020 3764 2341

Citigate Dewe Rogerson (Financial PR)

Mark Swallow/ David Dible

 

020 7638 9571

 

About Sareum

Sareum is a specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases. The Company aims to generate value through licensing its candidates to international pharmaceutical and biotechnology companies at the preclinical or early clinical trials stage.

Sareum is advancing internal programmes focused on distinct dual tyrosine kinase 2 (TYK2) / Janus kinase 1 (JAK1) inhibitors through preclinical development as therapies for autoimmune diseases, including the ‘cytokine storm’ immune system overreaction to Covid-19 and other viral infections, (SDC-1801) and cancer immunotherapy (SDC-1802).

The Company’s preclinical FLT3+Aurora inhibitor programme targeting haematological cancers is licensed to a China-based specialty pharma company.

Sareum also has an economic interest in SRA737, a clinical-stage oral, selective Checkpoint kinase 1 (Chk1) inhibitor that targets cancer cell replication and DNA damage repair mechanisms. Preliminary Phase 2 and comprehensive preclinical data suggest SRA737 may have broad application in combination with other oncology and immune-oncology drugs in genetically defined patients.

SRA737 was discovered and initially developed by scientists at The Institute of Cancer Research in collaboration with Sareum, and with funding from Sareum and Cancer Research UK. SRA737 was licensed by CRT Pioneer Fund (CPF) to Sierra Oncology Inc. Sierra continues to explore options that would enable the development of SRA737 to advance.

Sareum Holdings plc is listed on the AIM market of the London Stock Exchange, trading under the ticker SAR. For further information, please visit the Company’s website at www.sareum.com

 

  • @Sareumplc Latest tweet

    RT @HybridanLLP: Good to see Sareum's research on TYK2 as an oncology target referenced here. We see Sareum as a frontrunner in this space… via @Sareumplc
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